Royal Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Philips SmartCT application software. Amsterdam-based Philips’ SmartCT software is a component of the company’s Azurion image-guided therapy system for diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures. SmartCT helps to enhance clinical confidence, smooth the workflow and increase productivity through […]
FDA
Medtronic can’t shake suit over FDA clearance of spinal devices
A federal appeals court has ruled that Medtronic must face a whistleblower lawsuit over FDA clearance of certain spinal fusion devices. The Dan Abrams Company sued Medtronic in 2015 claiming that Medtronic defrauded the FDA into granting 510(k) clearance to certain Verte-Stack cervical vertebral body replacement (VBR) devices used in spinal fusion surgeries. The lawsuit […]
MTF Biologics says FDA used old data to malign its surgical mesh
A surgical mesh company claims the FDA improperly called one of its products’ safety into question. The agency said last week that two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates.” It named FlexHD by MTF Biologics and AlloMax by BD as having had higher rates of explantation, reoperations and infections two years […]
Feds put J&J in charge of vaccine production at Emergent plant
Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility. The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines. Get the full story at our sister site, […]
FDA clears Orthofix 3D-printed titanium cervical spacer system
Orthofix Medical (NSDQ:OFIX) announced today that it received FDA 510(k) clearance for its Construx Mini Ti spacer system. Lewisville, Texas–based Orthofix also administered the first patient implant of the 3D-printed Construx Mini Ti system, which is designed to enhance anterior cervical discectomy and fusion (ACDF) procedures, according to a news release. The Construx Mini Ti […]
FDA flags infection risk from reusable urological endoscopes
The FDA said today that is looking into the causes of infections from reprocessed urological endoscopes based on “numerous” adverse event reports. The agency said that since 2017 it has received more than 450 medical device reports — including three deaths — associated with reprocessed cystoscopes, ureteroscopes and cystourethroscopes used for viewing and accessing the […]
FDA authorizes use of over-the-counter COVID-19 tests for screening
The FDA announced today that it authorized several COVID-19 tests for over-the-counter use in asymptomatic screening. Among the tests authorized were the BinaxNow Ag card from Abbott (which includes point-of-care screening) and the Quidel Quick-View at-home test. FDA also authorized the BD Veritor Plus system for POC screening with a prescription. “BD is supporting the […]
FDA warns on use of certain surgical mesh in breast reconstruction
Two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis. Patients implanted with FlexHD by MTF Biologics and AlloMax by BD had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other […]
Abbott’s rapid COVID-19 self-test is now over-the-counter
Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for over-the-counter use of its BinaxNOW COVID-19 test. The new indication for the diagnostic allows individuals with or without symptoms to access the BinaxNOW COVID-19 Ag self-test over the counter, without a prescription. The company plans to begin shipping to major food, drug and […]
FDA approves inhaled pulmonary hypertension treatment from United Therapeutics
United Therapeutics (NSDQ:UTHR) announced today that it received FDA approval for its Tyvaso inhalation solution for pulmonary hypertension. Research Triangle Park, N.C.–based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release. Get the full story […]
BlueStar Genomics gains breakthrough nod for pancreatic cancer test
Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test. San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release. Get the full story at our sister site, Drug Delivery Business News.
